Prophylactic Antihistamine for Prevention of Hypotensive Transfusion Reaction After Blood Primed Cardiopulmonary Bypass in Pediatric Cardiac Surgery: a Randomized-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- hypotention episode incidance
研究概览
简要总结
This study will be a randomized, double-blinded, placebo-controlled study conducted at a university hospital. Forty children undergoing elective repair of a congenital heart defect will be included. The patients will be randomly allocated (20 patients per group) to receive a single intravenous dose of combined chlorpheniramine or normal saline immediately after separation from CPB, before protamine administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acyanotic congenital heart disease.
- •Age :1 -7 years.
- •Genre: both.
排除标准
- •Redo patient.
- •History of allergy to antihistamines.
- •Bleeding disorders with INR > 1.5 and/or platelets < 50,
- •Emergency procedure.
研究组 & 干预措施
Antihistamine
chlorpheniramine 0.25 mg/Kg in 2 ml
干预措施: Antihestamine (Drug)
control
equal volume of normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
hypotention episode incidance
时间窗: 15 min,post cardiopulmonary bypass weaning
Incidence of hypotension (20% MBP drop \< baseline)15 minutes post-CBP weaning
次要结局
未报告次要终点
研究者
Ahmed Mohamed Mohamed Elhaddad
assisstant professor
Kasr El Aini Hospital